Kornimate/medical-research-clean huggingface dataset:
long-term safety of 30 mg and 60 mg oral daily dose of ospemifene in the treatment of vulvar and vaginal atrophy (vva) in postmenopausal women with intact uterus

Conditions: Atrophy; Vaginal Diseases

Summary: the primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of vulvar and vaginal atrophy (vva) in postmenopausal women with an intact uterus.


Eligibility criteria:
inclusion criteria: * postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (vva) as assessed by vaginal ph, maturation index of vaginal smear, and self-reported symptoms at baseline for protocol 15-50310 * had an intact uterus * met the inclusion and exclusion criteria for protocol 15-50310 * had completed protocol 15-50310 exclusion criteria: * had clinically significant abnormal findings at the week 12 end of study visit for protocol 15-50310 * had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

Keywords: menopausal symptoms urogenital atrophy vulvar and vaginal atrophy in menopausal women vaginal atrophy
adp-a2m4cd8 in hla-a2+ subjects with mage-a4 positive esophageal or esophagogastric junction cancers (surpass-2)

Conditions: Esophageal Cancer; Esophagogastric Junction Cancer

Summary: this study will investigate the efficacy of adp-a2m4cd8 t-cell therapy in subjects who have the appropriate human leukocyte antigen (hla) and tumor antigen status and whose esophageal or esophagogastric junction (egj) cancer expresses the mage-a4 protein.


Eligibility criteria:
key inclusion criteria: * age ≥18 and \<75 years * diagnosis of esophageal cancer or esophagogastric junction cancer. * previously received treatment for advanced or metastatic disease. * measurable disease according to recist v1.1. * hla-a\*02 positive * tumor shows mage-a4 expression confirmed by central laboratory. * ecog performance status of 0 or1. * left ventricular ejection fraction (lvef) ≥50%. note: other protocol defined inclusion criteria may apply key exclusion criteria 1. positive for any hla-a\*02 allele other than: one of the inclusion alleles 2. history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study 3. active autoimmune or immune mediated disease 4. leptomeningeal disease, carcinomatous meningitis or symptomatic cns metastases 5. other prior malignancy that is not considered by the investigator to be in complete remission. clinically significant cardiovascular disease 6. uncontrolled intercurrent illness 7. active infection with human immunodeficiency virus, hepatitis b virus, hepatitis c virus, or human t cell leukemia virus 8. pregnant or breastfeeding note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: cell therapy t cell therapy spear t cell mage-a4 immuno-oncology metastatic esophagogastric junction esophageal cancer
dose ranging study of oto-201 in aomt

Conditions: Acute Otitis Media; AOMT

Summary: dose ranging study of oto-201 in aomt

this is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (aomt) will receive a single administration of 6 mg oto-201, 12 mg oto-201, or sham into the affected ear(s).

Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject is a male or female aged 6 months to 17 years, inclusive * subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (aomt) * subject's caregiver is willing to comply with the protocol an attend all study visits exclusion criteria includes, but is not limited to: * subject has a history of sensorineural hearing loss * subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation * subject has a history of known immunodeficiency disease

Keywords: acute otitis media with tympanostomy tubes otiprio
flow cytometry analysis of the reactive oxygen species in immature granulocytes in septic patient

Conditions: Sepsis

Summary: sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. early during sepsis course, immature neutrophils could be found in the bloodstream and may be less efficient than mature neutrophils in reactive oxygen species (ros) production. ros induce an oxidative stress for bacteria which can protect through the sos response. the main objective is to evaluate the level of ros produced in the early steps of sepsis by the immature neutrophils.

sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. the immune system is activated by both pathogen-associated and host-derived molecular patterns. a strong response of neutrophils is engaged and both innate and adaptive immune system homeostasis are strongly affected. neutrophils are able to produce high concentrations of inducible reactive oxygen species (ros), leading to an oxidative stress. ros can be released extracellularly at the site of infection or intracellularly in the phagolysosome. at early phase of sepsis, immature granulocytes are present in the bloodstream and could help to predict sepsis deterioration. however, it has also been shown that they are less efficient than mature granulocytes in ros production and phagocytosis. ros are potent stressors for bacteria and can directly or indirectly damage dna. bacteria can protect against dna damage through the sos response, which is a coordinated cellular response regulated by a repressor, lexa, and a sensor/activator, reca. the bacterial sos response is involved in acquisition of resistances to antibiotics through increasing frequencies of spontaneous mutations or increasing the expression of resistance and adaptation genes. the hypothesis that the low-level production of ros by immature granulocytes in the early steps of sepsis could be beneficial for both the host, as a high level of ros induce organ damage and dysfunction, and the pathogen, as low concentrations of ros would be able to induce the sos response allowing bacteria to enhance an adaptive response. the main objective it is to evaluate the level of ros produced by the immature granulocytes in septic patient. then, it will be assess if it could promote antibiotic resistance expression via sos-induced integron gene cassette rearrangements.

Eligibility criteria:
inclusion criteria: • adult patients hospitalized in icu or ed for acute sepsis exclusion criteria: * immunosupressed patients * active cancer * hiv * hematological or inflammatory diseases

Keywords: sepsis reactive oxygen species immature neutrophils
a phase i study of monoclonal antibody tb-402 in healthy male volunteers

Conditions: Healthy

Summary: dose escalation study to assess the safety and tolerability of tb-402, a monoclonal antibody directed against fviii, versus placebo in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * males 18 to 45 (groups 1-9) or 55 to 75 (group 10) years of age * no clinically important abnormal physical, laboratory, ecg findings * normal (or abnormal but ncs) supine blood pressure (bp) and heart rate (hr) exclusion criteria: * self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke. * any autoimmune disease. * previous allergic reaction to immunoglobulin. * present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment. * consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration. * abnormal platelet function or clinically significant out of range values for any coagulation tests. * history of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage. * screening fviii:c \< 50%.

Keywords: safety and tolerability
hypoglossal nerve stimulation on cardiovascular outcomes

Conditions: Obstructive Sleep Apnea

Summary: a new, well-tolerated treatment for obstructive sleep apnea - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. the study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.

obstructive sleep apnea, repetitive airway blockage during sleep, affects 1 in 10 americans. if left untreated, it results in decreased quality of life and increased risk of heart problems. only half of these people are able to use the main treatment, continuous positive airway pressure (cpap) therapy, which involves wearing a mask and hose at night. a new, well-tolerated treatment - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. the study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.

Eligibility criteria:
all patients recruited into the study will have already been implanted with the inspire® hgns device. additional inclusion criteria include: * as tolerating the therapeutic level during sleep can take time (weeks to months), all patients must be able to use the device at the therapeutic setting (\> 20 hours/week for \> 1 month) prior to enrollment, based on compliance data. * all patients will be english-speaking and able to give written informed consent. exclusion criteria include: * inspire® remote model 2500 or later is required. patients with older remotes are not candidates due to limited adherence monitoring capabilities. * patients who have fallen asleep while driving resulting in accident or "near miss" accident within 1 year prior to hgns implantation. * actively using positive airway pressure (pap) therapy for treatment of osa. * patients in whom the difference between sham and therapeutic voltages is less than 30% the therapeutic voltage. * pregnant women will be excluded.\* * women of childbearing potential must not be pregnant or plan on becoming pregnant. this study involves temporarily stopping treatment of obstructive sleep apnea, which may harm the fetus. if applicable, the patient will need to take a urine pregnancy test after enrollment (prior to washout #1), and again prior to washout #2.

Keywords: sleep apnea tongue stimulation cardiovascular function
assessment of influence of vitamin d on insulin secretion and sensitivity in obese teenage girls

Conditions: Vitamin D Deficiency; Insulin Resistance; Insulin Sensitivity; Obesity

Summary: the purpose of the study is to assess the relationship between vitamin d status and insulin- glucose dynamics in obese adolescents. the study is intended to assess the difference in the insulin sensitivity before and after correction of vitamin d deficiency.

the vitamin d deficient subjects are identified initially through an existing study. those identified with vitamin d deficiency are notified and subsequently treated with standard therapy for vitamin d deficiency as part of their clinical care. patients who self report that they have taken the treatment are enrolled in this study. patients will be evaluated in this study with measurement of serum 25 oh d level, pth and oral glucose tolerance test. the study will assess if there is improvement in glucose- insulin sensitivity dynamics once the serum 25oh d level is normalized

Eligibility criteria:
inclusion criteria: * female adolescents who are menarchal * bmi is 95th centile, for age and sex * patients will be screened for vitamin d deficiency through an existing study. * those found to be vitamin d deficient will be given standard treatment of vitamin d deficiency. * in this study, patients who self report that they had taken the treatment for vitamin d will be screened for serum 25 oh d level exclusion criteria: * children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications

Keywords: vitamin d deficiency insulin resistance glucose- insulin dynamics obese adolescents
japanese study of rimonabant in obese patients with dyslipidemia (venus)

Conditions: Obesity

Summary: the primary objective of this study is to assess the efficacy of sr141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks. secondary objectives are: * to evaluate the effect of sr141716 compared to placebo over a period of 52 weeks, on hdl-cholesterol and visceral fat area. * to evaluate the safety of sr141716 compared to placebo over a period of 104 weeks. * to evaluate the pharmacokinetics of sr141716.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 25 kg/m² * visceral fat area (vfa) \> 100 cm² * triglycerides (tg) \> 150 mg/dl and \< 700 mg/dl, and/or hdl-cholesterol \< 40 mg/dl(dyslipidemia) * at least 1 criteria of the following 2 comorbidities: * impaired glucose tolerance or type 2 diabetes * hypertension exclusion criteria: * patient with a secondary obesity. * patients who have received the diet therapy for less than 8 weeks before start of the observation period. * patients whose body weight changed by more than the variation of ± 2kg for screening period. * low compliance to drug intake (\< 80%) and dietary instruction during the observation period. * patients with type 1 diabetes. * patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type iii hyperlipidemia). * patients with a ldl-cholesterol \> 190 mg/dl at any of weeks -8 or -4. * patients with a secondary hypertension.

Keywords: obesity disease cannabinoid-1 receptor
ezetimibe plus atorvastatin versus atorvastatin in untreated subjects with high cholesterol (p03434)

Conditions: Hypercholesterolemia; Atherosclerosis

Summary: this study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing ldl-concentrations.


Eligibility criteria:
inclusion criteria: * male and non-pregnant female subjects, who demonstrated willingness to participate and comply with procedures by signing informed consent, and who were \>=18 years and \ =3.3 mmol/l (130 mg/dl) to \<=4.9 mmol/l (190 mg/dl); a baseline triglyceride concentration of \<3.99 mmol/l (350 mg/dl); a documented history of coronary heart disease (chd); a stable weight history for 4 weeks prior to baseline; completion of the designated washout periods for all prohibited medications; and did not fulfill any of the exclusion criteria for the study. exclusion criteria: * body mass index of \>=30 kg/m\^2 at baseline (increased to 35 kg/m\^2 in protocol amendment 1 * liver transaminase (alt, ast) \>1.5 times the upper limit of normal and with no active liver disease at baseline * evidence of current myopathy (excluding subjects with ck \>1.5 times above the upper limit of normal at baseline * clinical lab tests (cbc, blood chemistries, urinalysis) results outside the normal range or unacceptable to the investigator at baseline * type ii diabetes mellitus that was poorly controlled (hba1c\>9%), newly diagnosed, or changed their anti-diabetic therapy within 3 months of baseline * type i diabetes mellitus and not on a stable insulin regimen for 3 months prior to baseline or who had a recent history of repeated hypoglycaemia or unstable glycaemic control * known hypersensitivity to hmg-coa reductase inhibitors * alcohol consumption \>14 units (women)/21 units (men) (unit = 0.5 pint of beer or wine, or single measure of spirits) * pregnancy, lactation, or any condition or situation which, in the opinion of the investigator, posed a risk to the subject or interfered with participation in this study. * any of the following medical conditions: hiv positive; congestive heart failure defined by nyha as class iii or iv; uncontrolled cardiac arrhythmia; mi, acute coronary insufficiency, cabg, or angioplasty within 3 months of baseline; unstable or severe peripheral artery disease within 3 months of baseline; newly diagnosed or unstable angina pectoris at baseline; uncontrolled hypertension with systolic blood pressure \>100 mm hg at baseline; uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins; impaired renal function or nephritic syndrome at baseline; disorders of the hematological, gastrointestinal, or central nervous systems; diseases other than hyperlipidaemia or coronary heart disease that would have interfered with study evaluations; and cancer. * drug abuse or emotional or intellectual problems; * use of certain drugs, food, or other agents known to alter cholesterol levels or to cause pharmacokinetic interactions with either ezetimibe or atorvastatin
carbon-fibre accessory (cara) for supine breast positioning to reduce toxicity in whole breast radiotherapy

Conditions: Adjuvant Radiotherapy for Breast Cancer

Summary: this trial is designed to assess the efficacy of a novel carbon-fibre adjustable reusable accessory (cara) for breast support to reduce skin toxicity and unwanted normal tissue dose in comparison to the current clinical standard for supine breast support during whole breast rt.

this study is designed to assess the effectiveness of utilizing the cara positioning device for reducing the incidence and severity of acute skin reactions in the infra-mammary fold in patients undergoing wbrt. secondary outcomes include patient reported outcomes and dose to normal body tissue and organs at risk. this is a randomized controlled trial. participants will be randomly assigned to the following two arms: arm 1 patients will receive cara breast support. the known benefits to using cara for breast positioning are reduction in imf skin folds during treatment, reduction in breast separation, and reduction in v50% body, v105% body and lung v20 gy in treatment planning. no known risks to using cara have been identified. arm 2 patients will not receive cara breast support. patients in arm 2 may be treated with no breast support, a small foam wedge, a thermoplastic shell or alternate supine breast support method according to the current standard of care at the treating centre. these methods have entered rt clinical practice over decades of practice without published evidence of impact on rates of md. published rates of md for the control arm thus pertain to a cross section of these methods. the control arm of this study will look at all of these methods combined. there may be centre specific preference for the control method and stratification by centre will be done.

Eligibility criteria:
inclusion criteria: * age 18 or older. * able to provide informed consent * ecog performance status 0 - 2 * stage 0-3 invasive breast cancer or dcis scheduled to received adjuvant radiotherapy to the whole breast * any infra-mammary skin fold of \>= 0.5 cm in the supine treatment position and/or palpable lateral breast tissue falling posterior to the mid-axilla line while in supine or treatment position. exclusion criteria: * inability to give informed consent or comply with experimental arm of trial * previous rt to either breast or to the chest * planned boost to infra mammary area * use of mepitel while on treatment * failure to heal surgical wound or significant post-operative wound infection * presence of significant connective tissue disease (e.g. systemic sclerosis, sle) * known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia etc.) * breast reconstruction * planned partial breast irradiation, unless the treated area includes the infra-mammary fold
combination chemotherapy in treating patients who have extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. it is not yet known which combination chemotherapy regimen is most effective for extensive-stage small cell lung cancer. purpose: randomized phase iii trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.

objectives: * compare the effect of cyclophosphamide, doxorubicin, and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer. * compare the overall survival, response rate, duration of response, and toxic effects of these regimens in these patients. outline: this is a randomized study. patients are stratified according to institute and performance status (0-1 vs 2-3). patients are randomized to 1 of 2 treatment arms. * arm i: patients receive cyclophosphamide iv and doxorubicin iv on day 1, and etoposide iv on days 1-3 every 3 weeks. * arm ii: patients receive carboplatin iv followed by paclitaxel iv over 3 hours on day 1 every 3 weeks. patients with stable or responding disease are treated for up to 5 courses. patients are followed every 4 weeks. projected accrual: a total of 250 patients (125 per treatment arm) will be accrued within 24 months for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically proven extensive stage small cell lung cancer, not previously treated with chemotherapy or radiotherapy except for symptomatic brain metastases * measurable or evaluable disease * ascites, pleural effusions, osteolytic and osteoblastic bone metastases are not measurable or evaluable patient characteristics: age: * over 18 performance status: * ecog 0-3 life expectancy: * not specified hematopoietic: * platelet count at least 100,000/mm\^3 * absolute neutrophil count at least 2,000/mm\^3 hepatic: * bilirubin no greater than 1.25 times upper limit of normal (unless due to liver metastases) renal: * creatinine clearance at least 60 ml/min cardiovascular: * no cardiac failure or rhythm disturbances requiring medication other: * no history of hypersensitivity to castor oil * no active uncontrolled infection * no nonmalignant disease presenting a poor medical risk * not pregnant * fertile patients must use effective contraception during and for 3 months after the study prior concurrent therapy: biologic therapy: * no concurrent immunotherapy chemotherapy: * see disease characteristics * no other concurrent chemotherapy endocrine therapy: * no concurrent hormonal therapy radiotherapy: * see disease characteristics * palliative radiotherapy allowed (indicator lesion should be outside of irradiated field) surgery: * not specified

Keywords: extensive stage small cell lung cancer